Micro sewing device

ABSTRACT

The present invention discloses a micro sewing device for percutaneous, endoscopic, laporscopic and minimally invasive surgical procedures for suturing in very small internal body spaces. The device is of cylindrically specific design to provide suturing in the small spaces available.

BACKGROUND Field of the Invention

The present invention generally relates to sewing devices and morespecifically, to very small sewing devices for micro dimension precisionneeded in surgical environments.

Precision stitching in the last several decades has grown more widely inthe medical industry because simply, surgeons sew where they can toremove abnormalities or install continuing smaller medical devices. Itis a skill honed and mastered early, used virtually in every procedurethey are called upon to perform. Originating from basic fabric sewing,it is not that difficult and with practice relatively safe. However, thetrend in surgery of implanting medical devices organ removal and bypasstype surgical procedures has grown while device size has shrunk.

Some medical device manufacturing companies are now offering suturingsystems and devices aimed at delivering the tactile control andprecision associated with open procedures to minimally invasive surgery.

Present surgical procedures are challenged for device placement indifficult if not thought to be impossible locations previously and muchsmaller suturing work spaces. As medical devices grow smaller,components must become stronger to handle the resulting stresses, andsurgical techniques and tools must change to meet the challenge ofworking with yet smaller devices with smaller working spaces. Thisapplies to endoscopic, laporscopic and minimally invasive surgicalprocedures as well as more traditional medical procedures.

Some procedures for device implantation have proven inadequate becauseof weakened attachment and dislodged devices pose ongoing danger. Thesecuring of many medical devices such as stints requires suturing intotissue and onto new and tougher artificial materials, weaves andfabrics. The securing of these potentially dislodged devices isproblematic, requiring smaller sewing devices and stronger needles.Smaller devices so that generally means weaker needles, and anybreakages from weakened sutures or overstressed needles adds to theoperation risk. But smaller devices also means less intrusive means ofsuturing, simplifying the healing, and speeding recovery.

Where the risk is too high, a particular otherwise helpful medicalprocedure cannot be used. What is needed are smaller stitching devices,devices which can suture a running stitch or continuous chain ofstitching without tearing the tissue or the compromising the thread.What are needed are stitching devices which give the surgeon moreprecise thread control.

Very Small Tubular Devices

Catheters and other medical devices require very small tubular shapes toenable deployment in the arteries. Many products like Endovascular stentgrafts for abdominal and thoracic aortic aneurysms are made of tubularshaped graft material that is ether hand sewn together or precision sewnby machine like the small arm lock stitch machine as taught by SewFine™, in 2002 or on sewing devices like the Endovascular deploymentmachines used to sew deployment sheaths as taught by Sew Fine™, in 1997and additional equipment provided in 2006. Medical devices used inprocedures to support blood vessels, such as Endovascular stent graft,and devices to keep a vessel open, as in coronary stints, it is oftenthe case that the devices are smaller then can be sewn mechanicallybecause the precision cannot meet the dimensional requirements of thework.

The evolving requirements of medical devices and other non-medicaldevices press the envelope for sewing on smaller parts and yet smallerparts. In attaching Endovascular devices, it is often the case that asewn device requires a smaller more protective stitching needle thenwhat is currently available. Heart tissue weaknesses can be strengthenedwith suture repairs. Also, with new technologies evolving in thecoronary and other endovascular devices, it is necessary to sew closerto a stent or device than is currently possible. What are needed assmaller stitching devices, small enough to work around stent devices,yet strong enough not to break during the procedure with thread strongenough to last after the procedure.

What is needed are percutaneous surgeries that can be performed withoutrequiring little if any recovery time, and leaves no visible scars.

One such surgery is called Transgastric surgery, or natural orificetranslumenal endosurgery, and involves passing flexible surgical toolsand a camera in through the patient's mouth to reach the abdominalcavity via an incision made in the stomach lining. Once the operation isover, the surgeon draws any removed tissue out through the patient'smouth and stitches up the hole in the stomach. Surgeons have performedappendectomies through the mouth.

In many ways, transgastric surgery is a natural extension of keyholesurgery, in which slim surgical tools are inserted into the abdomen viasmall incisions in the skin, avoiding a large cut in the belly. It hasnow become routine for procedures such as gall bladder removal.

Transgastric surgery promises to go one better. Much of the discomfortand recovery time after conventional surgery, even keyhole surgery, isdue to the incisions made in the abdominal wall. However, becausetransgastric surgeons reach the abdominal cavity through the mouth,there is no need for an incision, so patients should be back up on theirfeet much faster. Although an incision is still made in the stomachlining, this is relatively painless, because the stomach has fewer nervefibers that register pain than our skin. The reduced pain also makes itpossible for the procedure to be carried without. Consequently, elderlyor infirm patients who would not be fit enough to receive a generalanesthetic, could still be treated.

Going in via the esophagus to the stomach may also reduce the risk ofpost-operative infections with, say, the drug-resistant superbug MRSA,which often lives on the skin. If you don't have skin incisions then youdon't get MRSA. And while there is a risk of infecting the abdominalcavity with bacteria from the gastrointestinal tract, animal studiessuggest that risk is small because stomach acid is cleansing.

What is needed is surgery that can be made pain-free, convalescence-freeand scar-free, whilst reducing the risk of complications and infections.

Stapling is used to close opened tissue in some procedures. However,staples instead of suture provide a large form body for the body toattack. Also stapling is not a flexible connector often altering theoriginal, natural attachment and the scar tissue is generally moreprevalent as a result of stapling. Also, with suture you have theoptions of using different types sizes and strength of suture. What isneeded are more suture options. Thus what is needed are micro sizedsuturing devices and procedures which can be used in endoscopic,laporscopic and minimally invasive surgical procedures.

Common Catheterization Procedures

The most common types of interventional catheterization procedures arethose performed to: create septal defects, open stenotic valves, openstenotic vessels, close abnormal vessels, or close certain septaldefects. Devices and procedures to do these kinds operations are needed,more efficiently and effectively, with less recovery time, smallerchances of infection, and all around cleaner.

Atrial septal defect (ASD) is a hole in the wall, septum, between theheart's two uppermost chambers, the right and left atrium. This holeallows blood to flow in either direction between the left and rightatrium. ASDs may cause several problems. First, this creates a conditionin which the right side of the heart now contains extra blood, and extrablood also now flows to the lungs. This diversion of blood puts strainon the heart because it has to pump this extra blood to the lungs. Inaddition, the strain put on the right-sided pumping chamber can lead toa weakening or enlargement of the right side of the heart and eventuallyheart failure, if left untreated. This enlargement may also causearrhythmias (irregular heart rhythms) to develop. This extra blood flowto the lungs may damage the arteries to the lungs over time, leading tohigh blood pressure in these vessels. Also, ASDs in some circumstancescan allow blood clots from the body to enter the brain and cause astroke. Open heart surgery is currently the only option and is done onlyafter all other solutions have failed. What is needed is a small deviceor procedure to close the hole invasively, so that more drastic,possibly catastrophic an expensive solutions are not the only option.

SUMMARY

The present invention discloses a micro sewing device having a needlerigidly coupled to a shank or needle bar; the shank or support barrotably coupled to an actuator arm; the actuator arm parallel andadjacent to a cylindrical looper cam; a cylindrical looper rigidlycoupled to the cylindrical looper cam; the looper cam with flutespitched in a helical configuration about the cam cylinder axis, withball drivers in the flutes; the flute pitch tuned to the rotationnecessary looper motion in concert with needle tip travel; the loopercam with a cylindrical sleeve like cam drivers on both cam ends,slidable coupled along the cam axis and concentric to the cam; each camdriver containing at least one ball driver trapped between the sleevecam driver and the cam, riding each cam flute; the actuator bar rigidlycoupled to the looper cam driver, and a housing enclosing the cam, camdrivers, and the actuator arm, whereby actuator arm movement will causethe needle tip locus to thread a stitch in concert with the looper,coupled to the moving cam driver turning the cam coupled to the looper,cam driver rotating the looper through pitched flutes in concert withthe needle point locus for a designed stitch.

The micro sewing device can sport another cam axially adjacent to thelooper cam and supported by another cam driver sleeve for more andenhanced synchronicity between the looper and needle, such that otherstitches can be made.

BRIEF DESCRIPTION OF DRAWINGS

Specific embodiments of the invention will be described in detail withreference to the following figures.

FIG. 1 is a perspective view illustration of a micro sewing deviceaccording to an embodiment of the present invention.

FIG. 2 is a perspective view illustration of a curved needle for insidewall to inside suturing with a micro sewing device according to anembodiment of the present invention.

FIG. 3 is a perspective view illustration of a curved needle and looperin in synchronous motion sequence for a stitch according to anembodiment of the present invention.

FIG. 4 is an illustration of a micro sewing device needle and looperstep wise stitching process according to an embodiment of the presentinvention.

FIG. 5 is an illustration of micro sewing device 401 stitch sequenceaccording to an embodiment of the present invention.

FIG. 6 is a perspective view of a straight needle micro sewing deviceaccording to an embodiment of the present invention.

FIG. 7 is a perspective view of catheter piloted micro sewing deviceaccording to an embodiment of the present invention.

DETAILED DESCRIPTION

Specific embodiments of the invention will now be described in detailwith reference to the accompanying figures.

In the following detailed description of embodiments of the invention,specific details are set forth in order to provide a more thoroughunderstanding of the invention. However, it will be apparent to one ofordinary skill in the art that the invention may be practiced withoutthese specific details in lieu of substitutes. In other instances,features have not been described in detail to avoid unnecessarilyduplication and complication.

Objects and Advantages

The present invention discloses a micro sewing device for very smalldimension surgical applications. The sewing device, is size adapted forendovascular operations, and for endovascular and or endoscopicmicro-suturing applications. Insertion of medical devices into vesselsto effect a repair and or remove blockage is common practice. However,stints have come loose or dislodged during normal use, and remotelysuturing medical components to vessel walls carries the inherentadvantage of not having to surgically open a body, yet still be able torepair and reuse.

In another objective of the invention, with sufficiently small andremotely manipulable devices, internal organs with damaged or otherwiseweakened tissue can be accessed and repaired through vessels. It is anobject of the present invention to provide a sewing device of dimensionssmall enough to insert through a vessel, to position adjacent to tissuerequiring repair, and subsequently repairs the tissue through sutcheringand reinforcing, adding strength to tissue so that deterioration isarrested and healing promoted.

Another object of the invention is to have the capability to sew off,that is the ability to sew the stitch without material. This also lendsitself to pre sewing, or having the device sew several stitches beforeit contacts the material to be sewn.

Another object of the invention is the use of straight or curved needleas to accommodate the sewing device requirements. All references to acurved needle will be a hypo curved needle, that is a hollow needlethrough which the thread or suture extends from a base oriface to thetip, to which the thread control passes.

It is an object of the invention to provide a percutaneous sewing deviceusing a (401) 2 thread chain lock. This involves a continuous 2 threadchain of stitches that can be used to close, connect, or pull. It iscommonly used for sewing products that require strength and stretch. Onepull of the trigger produces one stitch in a continuous chain ofstitches. Also this stitch can sew the 2 thread chain on or off thematerial being sewn. This enables the before and after ends to have amechanical tie off.

It is another object of the invention to provide a device to be used forlaparoscopic surgeries. In this application, the mechanical drivecomponents are external to the body and surgical site. The head of themachine will be designed to deliver the stitch from 45 to 180 degrees tothe tissue. The sewing head can be mounted to a catheter by moving themotion producing parts to the distal end of the device for endovascularsurgery. Other shapes and configurations of this technology can beutilized for specific procedures. It is another object of the inventionapplications related to laparoscopic surgeries. The stitch is a 401chain lock that is secured with 2 threads/sutures. One pull of thetrigger gives one stitch in a continuous chain of stitches. The sutureand the mechanical drive components will be external to the body. Thisstitch is used where considerable elasticity and give are required. Alsothis stitch can sew the 2 thread chain on or off the material beingsewn. This enables the before and after ends to have a mechanical tieoff.

Embodiments of the Invention

FIG. 1 is a perspective view illustration of a micro sewing deviceaccording to an embodiment of the present invention.

An embodiment of the invention is a small two thread or suture sewingdevice that sews a 401 chain lock stitch. This stitch has give but isstrong and is used for sewing article such as leather gloves and tennisnets. An embodiment of the invention also has the ability to sew thestitch without material, commonly referred to as sewing off. It alsolends itself to pre-sewing, or having the device sew several stitchesbefore it contacts the material to be sewn. This is a very necessarycharacteristic to have inside the body, as stable stitch ends must bemade to prevent unraveling and dislodging of repairs. In the Health careprofession as medical devices become smaller and more complex as seenwith endovascular stint grafts and tissue based products, the attachmentof the devices, anchoring, to prevent migration of the device becomesmore difficult. Many of the suturing technique are preformed with theaide of suturing devices that either require multiple instruments orhave a very limited stitching ability. An embodiment of the invention isintended to sew the 401 stitch type inside or outside of a body, solvingthe anchoring problem.

In another embodiment of the invention, the device is designed to bemounted to a endoscope or catheter type device. The head will be able torotate 360° and sew one stitch per pull of a triggering device. Take forinstance the procedure of gastric bypass surgery. This type of surgeryrequires a large number of stitches and a good degree of flexibility inthe stitch.

There are several instances where stitching inside the body provideslarge advantages. The reader will appreciate that closing the aorticappendage or Patent Foramen Ovale, surgery to close part of the Heartwith out open heart surgery is very difficult. Another application forthe invention is to repair an Anastamosis of parallel arteries and veinsin cases of compromised blood supply.

Another embodiment of the invention can be built such that the devicecams or motors are external to the body. Using the technology forminiaturization of small parts, an embodiment of the invention can beused for heart surgeries and be mounted on catheters or endoscopesdevices. With sufficiently strong needle technology, the needle can bemade very small and yet offer protection the suture as well. Anembodiment of the invention is designed to work with either a straightneedle or a curved needle.

FIG. 1 is a perspective and a side view illustration of a micro sewingdevice according to an embodiment of the present invention.

FIG. 1 shows the components of the device which includes a looper 101,curved needle 102, Needle bar 103, housing 104, looper cam driver 105sleeve, looper cam 106, needle cam driver 107 containing ball driverswhich ride the cam flutes, needle cam 108 with flutes at design pitchesdetermining the relative motion between the needle 102 and looper 1001,auxiliary cam driver 110 sleeve, and an actuator 111 linkage bar.

An aspect of the invention sewing device has a cylindrical design andthus a long axial dimension relative to its diameter which servesseveral functions, the internal percutaneous nature of its purpose ofentry through orifices and vessels which are tubular in geometry.

In an embodiment of the invention, the looper 101 is slidably coupled tothe looper cam 106, such that any axial helical forces are transferredfrom the looper cam 105 to the looper 101 via the looper cam driver 105.The actuator 111 is a linkage bar running parallel to the devicecylindrical axis inside the housing 104. Forces pushing and pulling onthe actuator I 1 1, move the needle bar 103 which controls the needle102 point locus of travel, and also axially move the looper cam driver105. The looper cam driver translates axial motion to the looper camdriver axial helical forces, twist turning the looper cam 106 whichrotate the looper 101 around the cylindrical axis in concert with theneedle 102. The looper cam driver 105 sleeve traps ball bearings in thedriver sleeve which travel in the looper cam 106 flutes. The flutes 109are of dimensions compatible with the ball drivers 102, which ride inthe cam drivers to rotate the helical flute cams. The flute pitchdetermines the amount of axial motion imparted to the needle bar 103 inrelation to the rotation imparted to the looper 101 via the looper cam106.

In another embodiment, a two cam arrangement is used. Any motion on theactuator 111 linkage conformably moves the needle cam driver 107 inaccordance with the needle cam 108 flute pitch, whose movement axiallydetermines the needle 102 point locus via the needle bar 103 coupling toan axial one bar linkage 114 to the needle cam driver 107.Synchronously, the needle cam 108 rotates and translates the needle 102,in concert with the looper cam 106 which rotates the looper 101. Theneedle cam 108 conforms concentrically to a sleeve 110 which is cap 113anchored to the housing 104.

FIG. 2 is a perspective view illustration of a curved needle for insidewall to inside suturing with a micro sewing device according to anembodiment of the invention.

What is shown sequentially is that the embodiment sewing device needlepoint 201 205 209 locus extends from inside a vessel wall, wall notshown, penetrating that wall and entering back into the vessel. Theneedle point 201 205 209 must have sufficient travel to make thenecessary stitch. Thus the synchronicity of the needle 201 205 209 andthe looper 203 207 211 respectfully, are accomplished by the designparameters of the helical cam 216 flute pitch which turns the looper,and the cam 216 traveler 219 one bar linkage 213 from the traveler 219to the needle 201 bar, which rotates the needle 201 205 209 through anarc. The needle head extends the curved needle 201 205 209 on an arcuentpath out through a tissue wall, not shown, and back into the tissueoriginating side, to stitch with the looper inside the tissue wall.

FIG. 3 is a perspective view illustration of a curved needle and looperin in synchronous motion sequence for a stitch according to anembodiment of the present invention.

A dwell in the looper cam holds the looper 302 at 9:30 as the needle 301begins to descend. As the needle 303 continues to descend the looper 304holds at 9:30. As the needle 305 enters the material the looper 306moves counter clockwise to 5:00.

As the needle begins to group the needle 307 thread gets caught on thelooper 308. After the chain is started as the needle starts descendingthe looper holds the looper suture at 9:30 to form a triangle for thesuture to enter as it goes through the material and into the needleplate. As the needle starts going up the needle suture forms a loop andthe looper catches the needle thread, not shown. As the needle goes upthe looper advances to 9:30. Holding the needle thread, not shown, onthe looper. As the looper goes back to 5:30 the needle suture, notshown, is cast off the looper forming a 2 suture chain stitch.

FIG. 4 is an illustration of a micro sewing device needle and looperstep wise stitching process according to an embodiment of the presentinvention.

Looking down on the device with the needle at 12:00 and priming thesewing device (starting the chain), with the looper and needle threaded401. The Needle descends 403 to bottom of its stroke bottom dead centerBDC 405. As the needle starts the up stroke 407 a loop is formed 409 inthe needle suture. The looper enters the needle suture loop 411. Theneedle continues to go up to Top dead center TDC as the looper moves to9:30 position. The needle goes down as the looper remains at the 9:30position entering in fount of the looper thread that is held behind theneedle entering position. As The needle enters the looper rotates fromthe 9:30 position to the 5:30 position. As the looper moves from the6:00 to the 5:30 position. The needle thread pulls off the looper, castoff. At this point the stitch has been formed. It is recommended this berepeated several times to start the chain.

FIG. 5 is an illustration of micro sewing device 401 stitch sequenceaccording to an embodiment of the present invention.

Stitch Formation by Steps

1. The needle is on the up stroke and forms a loop in the needle thread.The looper advances through the needle loop; 2. The needle is on the upstroke and looper advances through the needle thread.; 3. The needle isat TDP (top dead center) and is ready to be advanced to the next stitchlocation; 4. The needle is on the down stroke. The needle enters thethread triangle formed by the looper thread being held in the correctspot; 5. The needle is on the down stroke. The needle thread is cast offthe looper; 6. The needle in on the up stroke. The needle thread forms aloop and the looper goes through it; 7. The needle in on the up stroke.When the needle gets to top dead center the machine can be moved to thenext stitch location.

FIG. 6 is a perspective view of a straight needle micro sewing deviceaccording to an embodiment of the present invention. In someapplications, a straight needle is adaptable, where a curved needle willnot do. The straight needle rectangular support structure 601 rigidlycouples the needle shank 603 on one corner and the support bar actuator609 on the other looper 607 facing side corner. The straight needle 605is rigidly coupled to the needle shank 603. The needle 605 motion istoward the looper 607, whose motion is radially around the needle 605approach axis and perpendicular. The looper is rigidly coupled to thecam 619 head 613 via a stem 611 which rotates the looper 607 by virtueof the cam driver 615 axial motion. The cam driver rotates the cam 619via a ball driver fitted inside the cam driver sleeve. The cam driver isrigidly coupled to the needle support structure 601 via a bar linkage609. The turning cam 619 translates the cam driver 615 axially and thusthe needle 605 via the bar linkage 617. This is done in concert with thecam top 613 which rotates the looper 607 through rotation of the looperstem 611 rotating with the cam top 613. Thus as the cam turn, the camdriver moves the needle in and out of the looper inside planeperpendicular to the device central cylindrical axis.

FIG. 7 is a perspective view of catheter piloted micro sewing deviceaccording to an embodiment of the present invention. The sewing head707, and motion controller 703 are coupled by flexible catheter 705. Themotion controller 703 and the sewing head 707 function substantial asthe embodiments described, with the cam driver motion originating fromthe actuator bar 701. The manipulator or device position controller 703can be externalized. By remotely operating the actual stitchingfunction, an embodiment of the invention can provide even further devicesize reduction, providing a smaller internal foot print device. Thus byplacing the motion producing parts 705 at the distal end of the catheter705 and the looper and needle end 707 at the proximal end of thecatheter, this embodiment undergoes another effective size reduction.The catheter 705 as shown by a dotter line, contains two flexible buttorsion transferring wirelike components, coupled together butindependent force and torsion carrying wirelike components. Thisadditional internal footprint reduction allows this embodiment of theinvention to be used for telescopic and minimally invasive surgeries aswell as Vascular and endovascular procedures.

Therefore, while the invention has been described with respect to alimited number of embodiments, those skilled in the art, having benefitof this invention, will appreciate that other embodiments can be devisedwhich do not depart from the scope of the invention as disclosed herein.Other aspects of the invention will be apparent from the followingdescription and the appended claims.

1. A micro sewing device comprising: a curved hypo or straight needlerigidly coupled to a shank or needle bar; the shank or needle barrotably coupled to an actuator arm; the actuator arm parallel andadjacent to a cylindrical looper cam; a cylindrically curved looperrigidly coupled to the cylindrical looper cam; the looper cam withflutes pitched in a helical configuration about the cam cylinder axis,with ball drivers riding in the flutes; the flute pitch tuned to therotation defining looper motion in concert with needle tip travel; thelooper cam with a cylindrical sleeve like cam drivers on both cam ends,slidably coupled along the cam axis and concentric to the cam, housingthe ball drivers; each cam driver containing at least one ball drivertrapped between the cam driver sleeve and the cam, riding each camflute; the actuator bar rigidly coupled to the looper cam driver, and ahousing enclosing the cam, cam drivers, and the actuator arm, wherebyactuator arm movement determines the needle tip locus to thread a stitchin concert with the looper, coupled to the moving cam driver turning thecam coupled to the looper, cam driver rotating the looper throughpitched flutes in concert with the needle point locus for a designedstitch.
 2. The micro sewing device as in claim 1 further comprisinganother cam axially adjacent to the looper cam and supported by anothercam driver sleeve.
 3. The micro sewing device as in claim 2 furthercomprising another actuator bar rigidly coupled to the cam driver on thelooper cam end opposite the looper end.
 4. The micro sewing device as inclaim 1 further comprising an annular traveler riding the looper camflutes between two cam drivers, with traveler axially coupled to anactuating needle bar for movement in concert with the looper cam flutepitch determined looper rotation.
 5. The micro sewing device as in claim1 further comprising tuning the cam flute pitches for loop rotations andneedle movement to various stitches.
 6. The micro sewing device as inclaim 1 further comprising a curved hypodermic needle as described inU.S. patent application Ser. No. 11/975,868.
 7. The micro sewing deviceas in claim 1 further comprising a straight hypodermic needle.
 8. Themicro sewing device as in claim 1 further comprising a flexible catheterenclosure with force and torsion transmitting cables transmitting forcesand torsion from the cam-cam drivers-actuator-housing component motioncontrol integration to the suturing head integration containing theneedle-needle bar-looper components, whereby the suturing head can bemanipulated remotely and through the catheter from the integratedcomponent end comprising the motion control function.
 9. The microsewing device as in claim 1 further comprising a sew off a stitchwithout material, whereby a stitch maybe started or ended without looseend threads.